Search Results

The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

The PILLAR SA Ti Spacer System is an integrated in ody fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. The PILLAR SA TI Spacer System is compised of 3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws. The implants are offered in multiple footprints and lordotic options to accommodate individual patient anatomy. Each porous interbody has a large central window for graft material and a threaded hole with a zero-step locking mechanism for screw retention.

The PILLAR SA TI Spacer System implants are provided sterile.

PILLAR SA TI Spacer System implants are designed to be used with PILLAR SA TI Spacer System instrumentation and are not compatible with components from any other manufacturer's system.

This is a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. These types of notifications typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in the same way a diagnostic AI/ML device would.

Therefore, the provided text does not contain the kind of information requested for AI/ML device studies (e.g., acceptance criteria for performance metrics like sensitivity/specificity, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details).

Instead, the "acceptance criteria" for this device are related to its mechanical performance and substantial equivalence to existing devices. The study proving it meets these criteria is a non-clinical mechanical testing study.

Here's how to interpret the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of "patients" or "cases." The "sample size" here refers to the number of test specimens (implants) subjected to mechanical testing. This information is typically detailed in the full mechanical test reports, which are not included in this summary.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical test data, likely generated in a laboratory setting by the manufacturer (Orthofix, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not clinical expert consensus. The "experts" would be the engineers and technicians performing the tests and analyzing the results according to the specified ASTM standards.

4. Adjudication method for the test set:

• Not applicable. This is mechanical testing against predefined engineering standards (ASTM F2077, F2267, F1877), not expert adjudication of clinical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI/ML device.

7. The type of ground truth used:

• Engineering Standards and Benchmarking: The "ground truth" for this device's performance is its ability to meet or exceed the mechanical performance characteristics of predicate devices, as evaluated according to industry standards (ASTM F2077, F2267, F1877).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set."

In summary, the provided document is a 510(k) summary for a traditional medical device (intervertebral fusion device), not an AI/ML device. Therefore, the performance evaluation focuses on mechanical testing and substantial equivalence rather than clinical performance metrics and studies typical for AI/ML diagnostic tools.

Ask a specific question about this device

The O-GENESIS Graft Delivery System is intended to be used for the delivery of allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

The O-GENESIS Graft Delivery System is designed to deliver allograft, autograft or synthetic bone graft material to an orthopedic surgical site. The system consists of a loading syringe, a loading plunger, a loading funnel, a delivery cannula and a delivery gun with an actuating trigger handle. The system is provided sterile and is for single-use only.

In this 510(k) submission, the O-GENESIS Graft Delivery System is a Class II medical device (piston syringe) intended for delivering bone graft material to an orthopedic surgical site. The submission aims to demonstrate substantial equivalence to a predicate device, the GraftGun Universal Graft Delivery System (K170675).

The device in question is a bone graft delivery system, not an AI/ML powered device, so many of the requested elements for AI/ML performance studies (e.g., ground truth, MRMC study, training data, number of experts for ground truth establishment, adjudication methods, standalone performance, effect size of human reader improvement with AI) are not applicable.

However, I can provide information regarding the acceptance criteria for the functional performance of the device and how the study proved these criteria were met, based on the provided text.

Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the functional performance, material characteristics, and biocompatibility of the O-GENESIS Graft Delivery System compared to the predicate device. The acceptance criteria are implicitly derived from the successful completion of various tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Details of the Study

2. Sample sizes used for the test set and the data provenance:

   • The document states "Testing was performed using test units representative of the finished devices."
   • Specific sample sizes for each test are not explicitly mentioned in this summary. For example, it doesn't specify how many devices were subjected to simulated use, or how many individual tests were performed for each functional verification parameter.
   • Data Provenance: The studies were conducted by Orthofix, the device manufacturer, as part of their 510(k) submission. The data is prospective as it involves new testing of the manufactured device. The country of origin of the data is implicitly the United States, given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this device. This is a mechanical bone graft delivery system, not an AI/ML diagnostic or image analysis device that requires expert interpretation for ground truth. The "ground truth" here is the physical performance of the device (e.g., did it deliver the graft material, did the components withstand force, is it biocompatible). These are established through engineering and biological testing protocols, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are relevant for subjective interpretations (like radiology reads) to establish consensus ground truth. For mechanical and biological testing, results are objective (e.g., passed/failed a force test, biocompatible/not biocompatible based on standardized assays).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical tool, not an AI-powered diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This device integrates human operation (a surgeon uses the gun to deliver the graft), and there is no "algorithm only" component that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
     • For Simulated Use and Functional Verification: The ground truth is the successful operation of the device according to its design specifications and the ability to perform its intended function (delivering graft material) without failure. This is determined by direct observation and quantitative measurements (e.g., force required, successful actuation cycles) against pre-defined engineering acceptance criteria.
     • For Biocompatibility: The ground truth is established by laboratory test results (e.g., toxicity assays) conforming to the requirements of the ISO 10993-1:2009 standard.

8. The sample size for the training set:

   • Not applicable. This device is hardware; it does not involve an AI/ML model that requires a "training set" of data.

9. How the ground truth for the training set was established:

   • Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

Ask a specific question about this device

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:

a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion

When used for fixation to the illum, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow a surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System) and primarily focuses on proving substantial equivalence to a predicate device, not on presenting novel clinical study results for acceptance criteria in the typical sense of a new AI/diagnostic device.

The "acceptance criteria" here are mechanical performance standards for the spinal fixation system components and are met by demonstrating the new component (HA Coated Bone Screws) performs equivalently or better than the predicate device. The "study" is a series of non-clinical mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a numerical sample size for the mechanical tests. It refers to "the subject Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System HA (Hydroxyapatite) Coated Bone Screws" and "predicate Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Self-Tapping Cannulated Bone Screws." In mechanical testing, samples are typically specific numbers of manufactured devices.
• Data Provenance: The data comes from non-clinical performance testing conducted by the manufacturer, Orthofix, Incorporated. It is not patient or clinical data, so country of origin or retrospective/prospective does not apply in the typical sense. It's laboratory test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable. For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics measured against industry standards (ASTM). The determination of "substantial equivalence" is made by the FDA based on the submitted test results and comparison to predicate devices, not by clinical experts establishing ground truth on a test set.

4. Adjudication method for the test set

• This is not applicable. Mechanical testing does not involve adjudication of expert opinions. The test results are quantitative measurements compared against predefined standards or predicate device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. This submission is for a spinal fixation system, not an AI or diagnostic imaging device. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• The "ground truth" for the mechanical tests is defined by the industry standard specifications (ASTM F1717-12, ASTM F1798-97(2008)) for spinal implant systems and the measured performance characteristics of the predicate device (K130932). The goal was to show that the new HA-coated screws perform at least as well as the established, FDA-cleared predicate device against these objective mechanical benchmarks.

8. The sample size for the training set

• This is not applicable. No training set was used as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• This is not applicable. No training set was used.

Ask a specific question about this device

The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor: g) Pseudoarthrosis; h) Revision of previous surgery

The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) with nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

The provided document describes a 510(k) premarket notification for the Azure Anterior Cervical Plate System. This document is a regulatory submission for a medical device (a spinal implant), not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K130825 - Azure Anterior Cervical Plate System, SE) by removing constrained screws from the system due to a field failure mode. The performance data presented is related to mechanical testing of the spinal implant, not the performance of an AI/ML algorithm.

Therefore, I cannot populate the requested table and information as it pertains to an AI/ML device.

However, I can extract the relevant information regarding the modification to the device and the reason for the change, which led to a performance test.

Summary of Device Modification and Performance Study:

The purpose of this 510(k) submission is the removal of constrained screws from the Azure Anterior Cervical Plate System. This change was initiated because the constrained screw constructs were experiencing "total fracture of the locking mechanism" in the field.

A modified Dynamic Axial Compression test was conducted in accordance with ASTM F1717 standard to compare the performance of constrained and semi-constrained screws.

Acceptance Criteria and Reported Device Performance (for mechanical testing, not AI):

Regarding the specific questions about AI/ML studies:

1. Sample size for the test set and data provenance: N/A (Not an AI/ML device)
2. Number of experts used to establish the ground truth...: N/A (Not an AI/ML device)
3. Adjudication method: N/A (Not an AI/ML device)
4. Multi reader multi case (MRMC) comparative effectiveness study: N/A (Not an AI/ML device)
5. Standalone (i.e. algorithm only...) performance: N/A (Not an AI/ML device)
6. Type of ground truth used: N/A. The "ground truth" here is mechanical failure analysis (ASTM F1717 standard, field failure reports for constrained screws).
7. Sample size for the training set: N/A (Not an AI/ML device)
8. How the ground truth for the training set was established: N/A (Not an AI/ML device)

Ask a specific question about this device

The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

This document is a 510(k) premarket notification for the Orthofix Centurion POCT System, which is a spinal fixation system. It expands the indications for use of an existing device (K131833) to include the use of posterior screws in the cervical region of the spine.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not specify quantified acceptance criteria (e.g., specific tensile strength values, fatigue limits). Instead, the performance assessment relies on demonstrating equivalence to predicate devices through mechanical testing standards.

2. Sample Size Used for the Test Set and the Data Provenance:

The document mentions "mechanical testing" and "published literature". It does not specify a human "test set" or explicit sample sizes for the mechanical tests themselves.

• Sample Size: Not explicitly stated for specific tests, but implicitly refers to the number of test articles (implants) tested to meet the ASTM standards.
• Data Provenance: The document does not specify the country of origin. It relies on "mechanical testing per ASTM F1717 & F2706" and "published literature". These are laboratory tests, not data from human subjects. The data is likely prospective in the sense that the tests were performed specifically for this submission, although the standards themselves are established.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not applicable. This submission is for a spinal implant fixed via mechanical testing, not a diagnostic or prognostic device requiring expert interpretation of human data.

4. Adjudication Method for the Test Set:

• Not applicable. No human test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a mechanical spinal implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

• Mechanical Testing Standards: The "ground truth" for the device's performance is its ability to meet the established mechanical testing criteria outlined in ASTM F1717 and ASTM F2706. These standards define the acceptable mechanical properties (e.g., static and dynamic strength, torsion resistance) for spinal implant assemblies.
• Predicate Device Equivalence: The ultimate ground truth for this 510(k) submission is substantial equivalence to the legally marketed predicate devices, meaning it performs as safely and effectively as a device already on the market.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device submission based on mechanical testing and predicate device comparison, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, there is no training set for this type of device submission.

Ask a specific question about this device

CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

Cervical Stand Alone System

The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

This document is a 510(k) premarket notification for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System. It primarily addresses expanded indications for use, specifically the inclusion of allograft bone.

Based on the provided text, there is no acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered medical device. The document is for a medical implant (intervertebral body fusion device) and discusses its substantial equivalence to predicate devices, focusing on materials, design, and indications for use.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract information related to the clinical data that supported the expanded indication:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. The document does not define specific performance acceptance criteria for an AI/ML device. It discusses the "substantial equivalence" of the implant system to predicate devices based on design, materials, and intended use, and the safety of using allograft bone.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," not a specific test set with a defined sample size for this submission.
• Data Provenance: The data was "Published retrospective clinical data." The country of origin is not specified but implicitly relates to the use of similar cervical interbody fusion devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No ground truth establishment by experts for a specific test set is mentioned in the context of this 510(k) submission. The clinical data referred to supports the safety of using allograft bone.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This document is for a physical medical implant, not an AI/ML device, so an MRMC study related to AI assistance is irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This document is for a physical medical implant, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable in the context of an AI/ML ground truth. However, the "Published retrospective clinical data" would have relied on clinical outcomes data related to spinal fusion procedures and the use of allograft. The "outcomes demonstrated that the use of allograft... poses no new risks to patients."

8. The sample size for the training set:

• Not Applicable. No training set is mentioned as this is not an AI/ML device submission.

9. How the ground truth for the training set was established:

• Not Applicable. No training set or ground truth establishment for a training set is mentioned.

In summary, this 510(k) submission focuses on the substantial equivalence of a spinal implant system with expanded indications for use (specifically regarding bone graft material), rather than the performance of an AI/ML powered device.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation (T1 - S2/ Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: a) Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); b) Spondylolisthesis: c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumors: g) Pseudoarthrosis, and h) Failed previous fusion When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors.

The provided text describes a 510(k) premarket notification for the Firebird Spinal Fixation System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical or performance study in the way an AI/ML device would.

Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, AI performance metrics) is not applicable to this document as it pertains to a mechanical spinal fixation system, not a software or AI/ML device.

However, I can extract the relevant information regarding performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (spinal fixation system), "acceptance criteria" are typically defined by the standard mechanical tests and their pass/fail requirements, demonstrating that the modified device's performance is equivalent to the predicate device.

Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for this 510(k) submission is that mechanical testing demonstrates that the modified device (Firebird Spinal Fixation System with lined rods) is substantially equivalent to the predicate device (Firebird Spinal Fixation System K130932) and the other predicate (LDR Spine USA SpineTune TL System K120760) per the specified ASTM standards. The specific quantitative results (e.g., load-to-failure values, cycles to failure) are not provided in this summary, but the conclusion that equivalence was demonstrated indicates the acceptance criteria were met.

2. Sample size used for the test set and the data provenance:

• Sample size: The document does not specify the number of samples used for each mechanical test.
• Data provenance: The data provenance is from the mechanical testing performed on the device components themselves, adhering to specific ASTM standards in a laboratory setting. This is not clinical data (retrospective or prospective from a country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical device, and "ground truth" (in the context of expert consensus or pathology) is not established by human experts for mechanical performance testing. Ground truth for mechanical tests is the quantitative measurement of physical properties against engineering specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in studies involving interpretation of medical images or clinical outcomes. Mechanical testing does not involve this type of adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI. This document describes a spinal fixation system, which is a physical implant, not a diagnostic AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For mechanical performance testing, the "ground truth" is defined by the measured physical properties and performance characteristics (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1717-14, ASTM F1798-13) against the established performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As above, no training set is involved for this type of device submission.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following :
(a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
(b) spondylolisthesis,
(c) spinal stenosis
(d) trauma (i.e., fracture or dislocation).
(e) Atlanto-axial fracture with instability;
(f) Occipito-cervical dislocation:
(g) Tumors:
(h) Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1 - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, parallel axial connectors, and lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

The Orthofix Centurion POCT System is a spinal fixation system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The system's acceptance criteria are based on its substantial equivalence to predicate devices, demonstrated primarily through mechanical strength testing as per relevant ASTM standards.

Here's an overview of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify exact sample sizes for each mechanical test. However, "Mechanical testing" implies multiple units were tested to demonstrate performance against the specified ASTM standards.
• Data Provenance: The mechanical testing was conducted to support the substantial equivalence claim for the Centurion POCT System. This is typically done prospectively as part of product development and regulatory submission by the manufacturer (Orthofix Inc., a US company). The data would be considered prospective in the context of demonstrating performance for regulatory approval. The country of origin for the data is implicitly the United States as Orthofix Inc. is a US-based sponsor and the submission is to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• This information is not applicable to this type of submission. The "ground truth" for medical device mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles, not by human expert consensus or clinical pathology. The "experts" are the engineers and testing laboratory personnel who conduct and analyze these mechanical tests, adhering to the specified standards.

4. Adjudication Method for the Test Set:

• This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical tests yield objective, quantitative results directly comparable to established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable. The device described is a spinal implant for mechanical fixation, not an AI-powered diagnostic or interpretive tool that would involve human readers or image analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is defined by the established performance criteria within the specified ASTM standards and the "Guidance for Industry and FDA Staff Spinal System 510(k)s" document. The device components must meet or exceed these predetermined mechanical thresholds to be considered substantially equivalent and safe/effective. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• This is not applicable. As a physical implant, this device does not utilize a "training set" in the context of machine learning or AI development. The design and manufacturing processes are informed by engineering principles and prior device knowledge, rather than a data training set.

9. How the Ground Truth for the Training Set was Established:

• This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and nonpedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• . degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• . spondy lolisthesis,
• . trauma (i.e., fracture or dislocation),
• . spinal stenosis,
• . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• . tumor;
• . pseudoarthrosis, and
• failed previous fusion .
  When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
  The Phoenix MIS Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
  The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
  When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors. The expansion of indications for the Firebird Spinal Fixation System is proposed for the inclusion of adolescent idiopathic scoliosis alone, and not other indications for a pediatric population.
A subset of the Firebird Spinal Fixation System and Phoenix MIS System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.5mm to 7.5mm and lengths ranging from 25mm to 60mm.

The provided document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System. This type of regulatory submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a PMA.

Therefore, the document does not contain information about acceptance criteria and a study proving a device meets them in the way a diagnostic AI device or a novel therapeutic device would. Instead, it focuses on demonstrating equivalence to existing devices based on design, materials, indications for use, and mechanical performance.

I will attempt to extract the closest equivalents to your requested information where possible, based on the context of a 510(k) submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Device Performance

The Orthofix Firebird Spinal Fixation System is a Class III Preamendment Device (Pedicle screw spinal system) for which the manufacturer is seeking 510(k) clearance. A 510(k) clearance means the device is "substantially equivalent" to predicate devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. It typically does not involve traditional clinical studies with acceptance criteria for device classification as one would expect for a novel device or an AI/diagnostic product.

Therefore, many of the requested points below are not directly applicable or quantifiable from this document.

1. A table of acceptance criteria and the reported device performance

   Not applicable in the context of this 510(k) submission. The performance assessment is focused on "substantial equivalence" to predicate devices, primarily through mechanical testing and engineering analysis rather than specific clinical acceptance criteria.

   The document states:
   "Previous mechanical testing of the system included static and dynamic compression bending testing and static torsion testing per ASTM F1717-04 and finite element analysis."

   While these tests have criteria for compliance with the standard, the document does not present a table of these criteria alongside specific device performance data. The conclusion drawn is that the device is substantially equivalent based on these results.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   Not explicitly stated for the mechanical testing mentioned. When mechanical testing is performed, the "sample size" refers to the number of physical devices or components tested. The data provenance is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   Not applicable. Mechanical testing does not involve "experts" establishing ground truth in the way a diagnostic study would. The standards for mechanical testing (e.g., ASTM F1717-04) define the methods and parameters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   Not applicable. Mechanical testing does not involve adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   Not applicable. This is a spinal fixation system, not a diagnostic or AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   Not applicable. This is a spinal fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   For mechanical testing, the "ground truth" is defined by the physical properties and performance limits set by engineering standards (e.g., ASTM F1717-04). For the expansion of indications (specifically for adolescent idiopathic scoliosis), the document mentions: "Published clinical results and engineering analysis supported expansion of indications." This implies that existing clinical literature for similar predicate devices, combined with engineering analysis (which would include the mechanical testing), served as the basis for justifying the expanded indications. Outcomes data or expert consensus from previously published studies might have indirectly informed this, but no new study for this submission is detailed.

8. The sample size for the training set

   Not applicable. This is a spinal fixation system, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

   Not applicable. This is a spinal fixation system, not a machine learning model.

Summary regarding the Firebird Spinal Fixation System and 510(k) process:

The K130932 submission for the Firebird Spinal Fixation System is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to existing predicate devices. This is achieved by showing that the device:

• Has the same intended use.
• Has the same basic technological characteristics (design, materials: titanium alloy per ASTM F136 and cobalt chrome per ASTM F1537, as with predicates).
• Performs as safely and effectively as the predicate devices.

The "proof" the device meets acceptance criteria in this context relies on:

• Mechanical Testing: Static and dynamic compression bending, and static torsion testing per ASTM F1717-04.
• Finite Element Analysis (FEA).
• Comparison to existing predicate devices: K081684, K082797, K100044, K093926, K122901 (Orthofix Inc.), K113666 (Stryker Spine), K091445 (Medtronic Sofamor Danek USA), K994121 (Synthes Spine), K121630 (K2M, Inc.), K111492 (Medtronic Sofamor Danek USA).

The document states: "Previous testing performed on this device indicates that the Firebird Spinal Fixation System is substantially equivalent to predicate devices." and "Published clinical results and engineering analysis supported expansion of indications." This means the mechanical performance met relevant engineering standards, and the safety and efficacy for the expanded indications (specifically pediatric adolescent idiopathic scoliosis) were supported by existing clinical literature and the device's engineering characteristics being similar to already approved predicate devices.

Ask a specific question about this device

The AZURE Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

• a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
• b) Spondylolisthesis;
• c) Trauma (i.e., fracture or dislocation);
• d) Spinal stenosis;
• e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• f) Tumor;
• g) Pseudoarthrosis;
• h) Revision of previous surgery

The AZURE Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

The provided text describes the AZURE Anterior Cervical Plate System, a medical device, and its premarket notification. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices tested) for the mechanical tests. The data provenance is non-clinical, meaning it's from laboratory testing of the device itself, not from human or animal subjects. The testing was conducted in a laboratory setting to ASTM F1717-12 standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by expert medical consensus. The performance is objectively measured against the criteria defined by ASTM F1717-12.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical mechanical testing. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth for clinical data. Here, performance is determined by objective measurements meeting predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic or assistive AI system on human reader performance for interpretation of medical images or data. The AZURE Anterior Cervical Plate System is a physical implant, not a diagnostic or AI-driven system.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. Again, this device is a physical implant, not an algorithm. The performance evaluation is based on its mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance study (mechanical testing) is the established engineering specifications and performance thresholds defined within the ASTM F1717-12 standard. The device's ability to withstand static torsion, static axial compression bending, and dynamic axial compression bending according to this standard is the objective measure of its performance.

8. The Sample Size for the Training Set

This is not applicable. Training sets are used in the development of AI algorithms. This document is for a physical medical device (an anterior cervical plate system), not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical implant.

Ask a specific question about this device